NCT05549466

Targeted or Chemotherapy Combined With Immunotherapy Versus Chemotherapy for PD-1 Inhibitor Refractory R/M NPC

Antiangiogenic Therapy or Chemotherapy Combined With PD-1 Inhibitor Versus Standard Chemotherapy for PD-1 Inhibitor Refractory R/M NPC

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent problem in clinical practice. Based on previous clinical trials, anti-angiogenic drugs combined with immunotherapy were found to be effective. Therefore, this study intends to preliminarily evaluate which treatment regimen can provide the most benefit to PD-1 inhibitor refractory patients by comparing the efficacy of VEGFR inhibitor or standard chemotherapy combined with PD-1 inhibitor.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel)	Gemcitabine, iv, 1000 mg/m\^2, D1+D8, Q3W, 6 cycles; or capecitabine, po, 1250 mg/\^2, D1-14, BID, Q3W; or docetaxel, iv, 75 mg/m\^2, D1, Q3W. Apatinib, po, 250mg, qd. Camrelizumab, iv, 200mg, D1, Q3W.
DRUG	Apatinib, Camrelizumab	Apatinib, po, 250mg, qd. Camrelizumab, iv, 200mg, D1, Q3W.
DRUG	Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel)	Gemcitabine, iv, 1000 mg/m\^2, D1+D8, Q3W, 6 cycles; or capecitabine, po, 1250 mg/\^2, D1-14, BID, Q3W; or docetaxel, iv, 75 mg/m\^2, D1, Q3W. Camrelizumab, iv, 200mg, D1, Q3W.
DRUG	Chemotherapy (gemcitabine/ capecitabine/ docetaxel)	Gemcitabine, iv, 1000 mg/m\^2, D1+D8, Q3W, 6 cycles; or capecitabine, po, 1250 mg/\^2, D1-14, BID, Q3W; or docetaxel, iv, 75 mg/m\^2, D1, Q3W.

Timeline

• Start date: 2022-10-08
• Primary completion: 2023-09-20
• Completion: 2025-09-20
• First posted: 2022-09-22
• Last updated: 2023-02-08

Locations

1 site across 1 country: China